Major Depression Clinical Trial
Official title:
Event Related Potentials in Borderline Personality Disorder and Major Depression
NCT number | NCT01469663 |
Other study ID # | 5910 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | March 2015 |
Verified date | May 2021 |
Source | State University of New York - Upstate Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder. Unlike people who have depression alone (i.e. without borderline personality disorder), people with borderline personality disorder have depressions that often do not improve with medications. This makes treating depression much more challenging in someone with borderline personality disorder than without borderline personality disorder. Borderline personality disorderis associated with difficulty in understanding and communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the brain, the anterior cingulate. Depression is associated with changes in anterior cingulate activity. The investigators believe that when borderline personality disorder is present with depression, brain activity changes in the anterior cingulate will not be the same as in depressed patients without borderline personality disorder. An electroencephalogram records brain electrical activity. In this study, the investigators will measure electroencephalogram indices reflecting anterior cingulate activity. HYPOTHESIS: In this study, the investigators predict that when borderline personality is present with depression, electroencephalogram indices of anterior cingulate activity will be different from when depression is present alone (without borderline personality). This could help to explain why people with borderline personality have depressions that are harder to treat than depressions in people without borderline personality. The investigators also predict that electroencephalogram indices of the anterior cingulate will reflect emotional processing ability, as measured by validated questionnaires.
Status | Terminated |
Enrollment | 30 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - age between 18 and 45 - female - noncontrols diagnosis: major depression &/or borderline personality disorder - Control participants should have neither major depression or borderline pers. - meet Structured Controlled Interview for DSM - II cut off scores - meet Beck Depression Inventory (BDI)cut off scores - meet Borderline Evaluation of Severity Over Time(BEST) cut off scores. Exclusion Criteria: - based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview - schizophrenia - psychosis - Attention Deficit Hyperactivity Disorder - Obsessive Compulsive Disorder - bipolar disorder - mental retardation - dementia - CNS disease - Post-Traumatic Stress Disorder in non-borderline personality disorder groups - Recreational drug or alcohol use in the past week. |
Country | Name | City | State |
---|---|---|---|
United States | Syracuse University - CNY Medical Center | Syracuse | New York |
United States | Upstate Medical University | Syracuse | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York - Upstate Medical University | Syracuse University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Error related negativity amplitude | electroencephalogram amplitude of the error related negativity | on day 1 and then 4 weeks (average) later | |
Primary | N2 amplitude | electroencephalogram amplitude of N2 wave | on day 1 and then 4 weeks (average) later |
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